Effects of Dapagliflozin on 24-h Glycemic Changes in Japanese Patients with type 2 Diabetes Mellitus (T2DM), who Receives Basal supported Oral Therapy

Not Applicable

• Conditions: type 2 diabetes mellitus (T2DM)

• Registration Number: JPRN-UMIN000019457
• Lead Sponsor: Tokushima University Graduate School

Brief Summary

https://pubmed.ncbi.nlm.nih.gov/37028805/

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-01
• Study Completion: 2017-07-31
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

1. Type 1 diabetes mellitus, secondary diabetes mellitus 2. 3. Patients who have complications of severe hepatic disease , severe renal disease or receiving dialysis or recent 5 years malignancies. Patients with cardiovascular diseases (recent cardiovascular events, congestive heart failure, patients with uncontrolled high blood pressure) 4. Volume depleted patients (the study intends to enroll elderly patients over 65 who are more prone to volume depletion due to co-existing conditions and concomitant medications such as loop diuretics) 5. Patients with pregnancy, possible pregnancy, or on breast-feeding 6. Contraindication for the use of dapagliflozin 7. Patients who were received other sodium glucose cotransporter 2 inhibitor 8. Disqualified from the study by the primary investigator or a sub-investigator for any reason other than given above.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mean daily blood glucose level before (at Day 1-2) and after (at Day 3-4) add-on or no add-on of dapagliflozin

Secondary Outcome Measures

Name	Time	Method
Day 3-4 Change in fluctuation of 24-h blood glucose level, mean amplitude of glucose excursion, the percentage of time with glucose level >=180 mg/dL, >=70 to <180 mg/dL and <70 mg/dL from baseline Week 4 Change in HbA1c, body composition, TG, HDL-C, LDL-C, chylomicron, VLDL, MDA-LDL, adiponectin, high-sensitive CRP, 8-isoprostane, blood pressure, body weight, BMI from baseline Week 12 Change in the SD, mean and fluctuation of 24-h blood glucose level, mean amplitude of glucose excursion, the percentage of time with glucose level >=180mg/dL, >=70 to <180 mg/dL and <70 mg/dL, HbA1c, body composition, TG, HDL-C, LDL-C, chylomicron, VLDL, MDA-LDL, adiponectin, high-sensitive CRP, 8-isoprostane, blood pressure, body weight, BMI from baseline, Safety